FM - Procedures for New Study (Detailed Case Example)

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Last updated: Jul 25, 2013Version comment

The following procedures are provided as a case-example for a customer installation.   In this particular scenario, the institution will customize the StudyTRAX "Financial Management" Components based on the needs of each study/trial.  While a majority of the process is automated from the study staff prospective, two members of the staff will have unique roles to accommodate new studies that come on board.  The two roles will need to share frequent correspondence in order to ensure the quality of the process.

Procedure Contact:  Budget Manager

Topic: For the anticipated studyXXXXXX, create the associated Setup fees using the Administrative Setup Project.

Step 1:  Determine if this study is associated with an existing sponsor in the system, or, if a new sponsor must be created.

  • If the sponsor does not exist in the database, follow the instructions below to add sponsor.
  1. From the home page, select the Administrative Financing Manager project from the project selector in the silver bar.
  2. Check to be sure the sponsor does not already exist in the system as a subject.  If it does exist, advance to next bullet point below.
  3. Click "new subject" from the silver bar and enter the sponsor name as the "Reference ID".  Hit save and return.
  4. Enroll in project.
  5. Click edit subject from the silver bar and enter address info.  Hit save and return.
  • From the home page, Search for the sponsor and enter the Subject Overview page.

Step 2: Create the study setup fees

  • From the Subject Overview page, click on the encounters link from the left menu and select the green button on the far left called "Project Setup".
  • Fill out the form information according to the Study Setup fees for this upcoming StudyXXXXXX.  Hit Save and Return.

Note:  Always have the encounter date be exactly the same as the invoice date, unless the invoice date is a later date that has yet to be determined.

Topic:  Create a Budget for the anticipated study using the Master Budget Template spreadsheet.

Step 1:  Open the latest YYYYMMDD_Master Budget Template.xls spreadsheet, Rename and Save As StudyXXXXXX.xls.

Step 2:  Using the StudyXXXXXX.xls spreadsheet, modify (or) remove the number of columns, and rename the intervals(Encounters) per the study.

Step 3:  Use a Dark Gray Background Shade and color the rows that are not applicable at any interval in this study.

Step 4:  If necessary, adjust the default pricing rates where it makes universal sense .  (e.g. if a majority of the prices are different from the default rate, in any one row.)  Use a Dark Red Background Shade and color the default pricing rate cells, when a change is applied.

Step 5:  Begin adding pricing amounts to each cell where applicable to the budget.

  • Use a Light Red Background Shade and highlight cells that are different prices from the row's default pricing rate.
  • Use a Light Gray Background Shade, and color the cells that are NOT to be used during any one interval.

[ Save the StudyXXXXXX.xls spreadsheet, attach and mail to Study Administrator.  ]

Next Action: If the default pricing rates were changed,  await email from Study Administrator that the Master Budget Template has been modified in StudyTRAX and that the project has been developed.  Once received....See Step #6 below.

Step 6: Update Master Budget Template spreadsheet

  • Using the current YYYYMMDD_Master Budget Template.xls spreadsheet and the StudyXXXXXX spreadsheet, update the Column with the Default Pricing Rates ONLY.  This will ensure the default rates are current with the default rates on StudyTRAX database.  Save As YYYYMMDD_Master Budget Template.xls spreadsheet with the current date.

COMPLETE

Procedure Contact:  Study Administrator

Topic:  Upon receipt of the StudyXXXXXX.xls spreadsheet, Create a new study utilizing the financial component.

Step #1:  Click on the projects main menu item at the top of the screen.  Determine if Default price rates need to be updated.

  • If the StudyXXXXXX.xls  spreadsheet indicates changes to the default pricing list (dark red), follow steps 1 through 4.
  1. Click on the Financial Management Master project.
  2. Click on the Variable Groups link in the left hand menu.
  3. Click on the Financials Encounter variables group, then select dependencies from the left hand menu.
  4. Follow the instructions and update the prices from the items on the StudyXXXXXX.xls spreadsheet(red).  Hit Save and Return.

Step #2:  A new study is created as a copy of the Financial Management Master.

  • On the Financial Management Master row, Click on the small export icon on the far right side of the screen.
  • Save Financial Management master.xml file to desktop.
  • Click on the Import Project link in the left hand menu.
  • Enter License Key and enter the name of the study as New Project Name.  Click submit.

Step #3:  Update the pricing of each interval according to the budget.

  • Click on the StudyXXXXXX project and click on the Intervals link in the left hand menu.
  • Create all intervals relevant to the study.
  • Click on the Invoicing  interval link, then select the interval expression link in the left hand menu.
  • Select all the code and copy (Ctrl-C).
  • Return to EACH NEW interval created for this study and paste this code into its interval expression.  Hit save and return after each paste.
  • Repeat Steps 1 to 4 for each new interval created x.
  1. Once again, enter the interval expression for interval x, Follow the instructions, remove the double slash (//) marks on the far left of the screen for each Study Event, Lab, Study Staff and Stipend according to the budget.
  2. Be sure to update the NAME of the Study Others, Lab Others and Stipend Others being utilized for the budget.
  3. Be sure to update the number of hours when a study staff is being utilized according to the budget.
  4. Update the Overhead Percentage, if necessary, for interval x according to the budget.

Step 4:  After all intervals are adjusted as necessary, double check your work.  When ready, delete the "Invoicing" interval.

Step 5:  Review the Unstructured Event Encounter

  • Click on the Unstructured Event Encounter, enter the interval expression and update the Overhead Percentage according to the planned budget.
  • In addition to the SAE, if there is a need to include other pricing events (not common) for this "Non-Fixed interval" called Unstructured Event, follow steps 1 and 2.
  1. Follow the instructions, remove the double slash (//) marks on the far left of the screen for any potential event that could potential be unstructured.
  2. Be sure to update the NAME of the Study Others, Lab Others and Stipend Others if being utilized as unstructured.

Next actions:  [ The Study Administrator is now ready to confirm with the Budget Manager that the Master Budget Template has been modified in StudyTRAX according to the StudyXXXXXX.xls spreadsheet template.   The financial components for this study have been implemented ]

  • At this point, the study can be developed with the appropriate CRF's as normal.  Patients can be enrolled into the study per the protocol.

NOTE:  As the study proceeds, when necessary, adjustments to the study pricing at any one subject encounter can be accomplished.

COMPLETE